Closure Devices for Large Bore Arterial Access
Published date : 27 June 2013
Article date : 27 June 2013
Author: Dr Douglas F Muir MB ChB FRCP, a Which Medical Device Specialist Editor: Coronary Intervention and Consultant Interventional Cardiologist at the Cardiothoracic Division, The James Cook University Hospital, Middlesbrough, UK. Disclosure: The author is a proctor for Edwards Life Sciences.
Dr Muir's major clinical interests are complex PCI: LMS, rotational atherectomy, CTO and TAVI. A proctor and faculty trainer for the Edwards Sapien TAVI system, he has a strong interest in procedural technologies which allow more complex procedures to be undertaken in safer and more reliable ways. Here, Dr Muir examines a number of closure devices in relation to large bore arterial access.
Introduction
Traditionally, cardiac or peripheral interventions have involved relatively small sheaths (5F – 8F) with haemostasis being achieved with manual pressure. More recently, a range of closure devices has been made available (e.g. Angioseal, Exoseal, Perclose) which offer the possibility of more convenient haemostasis and earlier ambulation. However, meta-analysis has not demonstrated superior clinical outcomes with closure devices (1) and the reduced vascular complication rate with transradial access (2) has prompted a marked trend away from the femoral artery for PCI.
Transcatheter Aortic Valve Implantation (TAVI) and Endovascular Aneurysm repair (EVAR) require much larger sheath sizes for device delivery – typically 12-24F for EVAR and 16F – 24F for TAVI. These procedures therefore create challenges for haemostasis and minimisation of vascular complications.
In TAVI, both Edwards Sapien and Medtronic CoreValve have continued to reduce sheath sizes with newer device iterations. Edwards Sapien XT requires 16F, 18F or 20F expandable “eSheath” for 23mm, 26mm and 29mm devices respectively, whereas Medtronic CoreValve requires 18F sheath across all valve sizes – 23mm, 26mm, 29mm, and 31mm.
Many TAVI teams have favoured open surgical cut-down and repair for transfemoral (TF) access; however groin closure devices offer truly percutaneous procedures with the possibility of local anaesthesia only and the potential to improve ambulation.
There are 2 commonly used devices for TF TAVI: the Prostar XL and the Perclose Proglide, both suture based and manufactured by Abbott.
Prostar XL
The Prostar XL is licensed for closure of 8.5F – 24F access sites. A pre-closure technique is used for implantation. Once the vessel has been punctured through an appropriate skin incision, blunt dissection over the wire down to the arteriotomy site is performed. This step is very important to allow the introduction of the 10F proximal section of the device and to allow the retrograde passage of the 4 needles back through the front wall of the artery to be retrieved externally.
The device is advanced with gentle rotation over the wire and the vessel lumen is confirmed by bleed back through a small channel at the proximal end. The wire is removed and the needles are pulled back through the arteriotomy site, externalised and cut from the suture ends. The Prostar XL is partly withdrawn to allow the 4 suture ends to be harvested and clipped aside, thus creating 2 sutures criss-crossed through the arteriotomy. As the device is withdrawn further, the wire is reintroduced and the desired large sheath implanted.
After completion of the TAVI or EVAR procedure, the operator then hand-ties two “fisherman’s knots” on the sutures which are then slid down to the arteriotomy site with a supplied knot pusher. As the sheath is withdrawn completely, the knots are sequentially pushed down to the vessel wall with the wire left in place. At this stage, a small amount of bleeding is expected around the wire. If bleeding is profuse, the retained wire allows the option of implanting a second device. Once the desired reduction in bleeding is seen, the wire is removed and the knots slid further down onto the vessel wall. The knots are then locked and cut to complete haemostasis.
Tips for use:
- A central vessel puncture is required - away from bifurcations and front wall calcium. Careful study of CT angiography and intra-procedural ultrasound may help.
- Blunt dissection should be performed to ease passage of needles and suture knots.
- In very obese patients with very deep arteries, it may not be possible to advance the Prostar XL to the arteriotomy, thus causing closure failure.
- The sutures may dry out and prevent the knots from sliding; they should be kept lubricated throughout.
- Avoid pulling the sutures too tight as they are prone to snapping.
Perclose Proglide
The Perclose Proglide is only licensed for 5-8F arterial closure, so the method described is “off label”, though safe use has been described in both TAVI and EVAR(3, 4). Again, a pre-closure method is used.
After vessel access has been gained through an appropriate skin incision, a Perclose Proglide device is introduced over the wire, which is then removed. The vessel lumen is identified by bleed back through a small external channel and an external handle deploys the device “foot”. The whole device is gently pulled back until resistance is felt against the arterial wall and a plunger is depressed to fire the suture back into the handle. The suture is then cut, retrieved and clipped aside. The “foot” is retracted by reversing the initial manoeuvre and the wire re-inserted through the partially withdrawn device to maintain the lumen. A second device is then deployed in an identical fashion, but at an angle to the first suture. The wire and suitable sheath are introduced to allow the procedure to take place.
On completion of the TAVI or EVAR procedure, the knots are already tied. The supplied knot pusher is used to slide the knot down to the arteriotomy and the process is repeated for the second suture as the sheath is completely removed. As above, a small amount of bleeding is to be expected around the wire but a third or even fourth device may be used if this is extensive. The wire is removed completely; the knots are pushed down fully, locked and cut.
Tips for use:
- As with Prostar XL, a central vessel puncture is required away from bifurcations and front wall calcium. Careful study of CT angiography and intra-procedural ultrasound may help.
- Blunt dissection does not usually have to be as extensive as with Prostar XL.
- Deploy the 2 devices at an angle to each other; most commonly at “10 o’clock” and “2 o’ clock”.
- Tie the knots of the devices in the order they were implanted.
- Avoid pulling the sutures too tight as they may snap.
Comparison of Methods
No randomised trials comparing the methods described exist.
In our institution, the TAVI programme has evolved through an initial phase of open cut-down and repair, through sequential evaluation of both the methods described above. While cut-down is less expensive, it adds to the procedure time and often causes more discomfort and slower ambulation post procedure.
Of the closure devices described, the Prostar XL is arguably the more elegant device and is CE marked to 24F, but there is a learning curve with knot tying and the sutures seem more fragile.
We have found the double Proglide method to be quicker and more reliable, though “off label”. Depending on local arrangements, 2 Proglides are significantly less expensive than one Prostar XL, an effect which becomes magnified in the event of device failure and requirement for further device implant. We now use the double Proglide method routinely for all TF TAVI procedures.
References
1. Nikolsky E et al. Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: A meta-analysis. Journal of the American College of Cardiology, Volume 44, Issue 6, 15 September 2004, Pages 1200-1209.
2. Jolly SS et al. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. The Lancet 23 April 2011 (Volume 377 Issue 9775 Pages 1409-1420).
3. Griese, DP et al. Simple, effective and safe vascular access site closure with the double-proglide preclose-technique in 162 patients receiving transfemoral transcatheter aortic valve implantation. Catheterization and Cardiovascular Interventions. 2013 Jun 14. doi: 10.1002/ccd.25053. [Epub ahead of print]
4. Kim WH et al. Efficacy and safety of the preclose technique following percutaneous aortic stent-graft implantation. J Endovasc Ther. 2013 May;20(3):350-5. doi: 10.1583/12-4103MR2.1.
